Ability to perform important repair procedure to rework medical electronic systems returned from field service. Procedure includes partial disassembly, modification of subassemblies, addition of new assemblies, complete system test and repackaging according to procedures.
Essential duties and responsibilities include the following. Other duties may be assigned.
Electromechanical assembly and test of medical devices.
Demonstrated soldering ability with modern no-clean materials and familiar with basic electronic measurement tools: Multimeter, Frequency Generator, Oscilloscope, Power Supplies, etc.
Manual Dexterity with small to medium assemblies including wiring harnesses, metal and plastic enclosures with gasket seals using threaded fasteners, with manual and power tools, torque drivers etc.
Ability to propose changes in design fixtures to increase efficiency of the repair and assembly process.
Understanding of ESD preventive procedures as well as electromechanical medical device FDA cGMP procedures.
Ability to operate computer controlled automated electronic test equipment.
Familiarity with LabView a plus.
Focused on quality work and craftsmanship.
Results oriented with the ability to accomplish work in a team environment and communicate with management regarding operational issues and/or improvements.
Perform duties in compliance with applicable regulations and standards such as FDA Quality System Regulation and ISO (International Organization for Standardization).
Maintain a professional and credible image with FDA and other regulatory agencies, consultants, vendors, and co-workers.
Promote safety as the most important value in the organization by adhering to and enforcing all safety policies and procedures by maintaining overall cleanliness of the distribution center to include the proper storage of all materials and equipment.
Create “Work Instructions” in Microsoft Word to capture the work steps required for a particular process.
Route Engineering Change Orders in SAP for the changes to existing work instructions as well as release purchasing specifications for sub-components of the equipment that servicing cell requires to complete a new repair.
Familiarity with Installation qualification, Operational qualification and Process qualification efforts and the trouble shooting that goes along with each phase in development.
High School Diploma or equivalent and one to two years related experience; or equivalent combination of education and experience.
Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to speak effectively before groups of customers or employees of the organization.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables.
The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.
While performing the duties of this job, employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, risk of electrical shocks, explosives, risk of radiation, and vibration.